Application No | Product Name | Dosage Form | Strength | Pack Size | NDC Number | Medication Guides | Prescribing Information |
|---|---|---|---|---|---|---|---|
ANDA077712 | Oxycodone Hydrochloride Tablets | Tablet | 5 mg | 100's HDPE | 64380-259-01 |
|
|
500's HDPE | 64380-259-02 | ||||||
1000's HDPE | 64380-259-03 | ||||||
10 mg | 100's HDPE | 64380-260-01 | |||||
500's HDPE | 64380-260-02 | ||||||
15 mg | 100's HDPE | 64380-261-01 | |||||
500's HDPE | 64380-261-02 | ||||||
1000's HDPE | 64380-261-03 | ||||||
20 mg | 100's HDPE | 64380-262-01 | |||||
500's HDPE | 64380-262-02 | ||||||
30 mg | 100's HDPE | 64380-263-01 | |||||
500's HDPE | 64380-263-02 | ||||||
1000's HDPE | 64380-263-03 | ||||||
ANDA076744 | Testosterone Gel, 1% | Gel | 2.5 g | 1 sachet | 64380-151-01 |
|
|
30's sachet in carton | 64380-151-02 | ||||||
5 g | 1 sachet | 64380-152-01 | |||||
30's sachet in carton | 64380-152-02 | ||||||
ANDA204558 | Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP, 236 grams/2.97 grams/ 6.74 grams/5.86 grams/22.74 grams/4 Liter | Oral Solution | Unflavored | 4 L Jug | 64380-765-21 |
|
|
Lemon flavor | 4 L Jug | 64380-766-21 | |||||
Orange flavor | 4 L Jug | 64380-767-21 | |||||
ANDA210078 | Diclofenac Potassium Capsules (SGC) | Capsule | 25 mg | 60's HDPE | 64380-841-03 |
|
|
100's HDPE | 64380-841-06 | ||||||
120's HDPE | 64380-841-11 | ||||||
ANDA208247 | Roflumilast Tablets | Tablet | 250 mcg | 14s Blister | 64380-287-01 |
|
|
2x14's blister | 64380-287-02 | ||||||
500 mcg | 30's HDPE | 64380-786-01 | |||||
90's HDPE | 64380-786-05 | ||||||
ANDA091055 | Emtricitabine & Tenofovir Disoproxil Fumarate tablets (PEPFAR) | Tablet | 200/300 mg | 30's HDPE | 42543-719-04 |
|
|
30's HDPE | 64380-719-04 | ||||||
ANDA078418 | Topiramate Capsules | Capsule | 15 mg | 60’s HDPE | 64380-241-01 |
|
|
500’s HDPE | 64380-241-02 | ||||||
25 mg | 60’s HDPE | 64380-242-01 | |||||
500’s HDPE | 64380-242-02 | ||||||
50 mg | 60's HDPE | 64380-240-01 | |||||
500's HDPE | 64380-240-02 | ||||||
ANDA079021 | Atomoxetine Hydrochloride Capsules | Capsule | 10 mg | 30's HDPE | 64380-472-01 |
|
|
500's HDPE | 64380-472-02 | ||||||
18 mg | 30's HDPE | 64380-473-01 | |||||
500's HDPE | 64380-473-02 | ||||||
25 mg | 30's HDPE | 64380-474-01 | |||||
500's HDPE | 64380-474-02 | ||||||
40 mg | 30's HDPE | 64380-475-01 | |||||
500's HDPE | 64380-475-02 | ||||||
60 mg | 30's HDPE | 64380-476-01 | |||||
500's HDPE | 64380-476-02 | ||||||
80 mg | 30's HDPE | 64380-477-01 | |||||
500's HDPE | 64380-477-02 | ||||||
100 mg | 30's HDPE | 64380-478-01 | |||||
500's HDPE | 64380-478-02 | ||||||
ANDA214673 | Levetiracetam Oral Solution | Oral Solution | 100 mg/mL | 473 ml HDPE | 64380-960-01 |
|
|
5 ml unit dose cup | 64380-960-02 | ||||||
10 cups in a tray | 64380-960-03 | ||||||
ANDA206943 | Gabapentin Capsules | Capsule | 400 mg | 100's HDPE | 64380-731-01 |
|
|
500's HDPE | 64380-731-02 | ||||||
1000's HDPE | 64380-731-03 | ||||||
100 mg | 100's HDPE | 64380-753-01 | |||||
500's HDPE | 64380-753-02 | ||||||
1000's HDPE | 64380-753-03 | ||||||
300 mg | 100's HDPE | 64380-754-01 | |||||
500's HDPE | 64380-754-02 | ||||||
1000's HDPE | 64380-754-03 | ||||||
ANDA203244 | Gabapentin Tablets | Tablet | 600 mg | 100's HDPE | 64380-727-01 |
|
|
500's HDPE | 64380-727-02 | ||||||
800 mg | 100's HDPE | 64380-728-01 | |||||
500's HDPE | 64380-728-02 | ||||||
ANDA212683 | Fluoxetine Tablets | Tablet | 60 mg | 30's HDPE | 64380-900-04 |
|
|
ANDA075938 | Propafenone Hydrochloride Tablets | Tablet | 300 mg | 100's HDPE | 64380-163-01 |
|
|
225 mg | 300's HDPE | 64380-164-01 | |||||
100's HDPE | 64380-164-02 | ||||||
150 mg | 300's HDPE | 64380-165-01 | |||||
100's HDPE | 64380-165-02 | ||||||
ANDA075938 | Propafenone Hydrochloride Tablets | Tablet | 300 mg | 100's HDPE | 64380-246-01 |
|
|
225 mg | 300's HDPE | 64380-268-01 | |||||
100's HDPE | 64380-268-02 | ||||||
150 mg | 300's HDPE | 64380-269-01 | |||||
100's HDPE | 64380-269-02 | ||||||
ANDA090055 | Mycophenolate Mofetil Capsules | Capsule | 250 mg | 100's HDPE | 42543-988-06 |
|
|
500's HDPE | 42543-988-07 | ||||||
100's HDPE | 64380-726-06 | ||||||
500's HDPE | 64380-726-07 | ||||||
120's HDPE | 64380-726-11 | ||||||
15's blister | 64380-726-17 | ||||||
ANDA088292 | Imipramine Hydrochloride Tablets | Tablet | 10 mg | 100's Bottle | 64380-169-01 |
|
|
1000's Bottle | 64380-169-02 | ||||||
ANDA088262 | Imipramine Hydrochloride Tablets | Tablet | 25 mg | 100's Bottle | 64380-170-01 |
|
|
1000's Bottle | 64380-170-02 | ||||||
ANDA088276 | Imipramine Hydrochloride Tablets | Tablet | 50 mg | 100's Bottle | 64380-171-01 |
|
|
1000's Bottle | 64380-171-02 | ||||||
ANDA040640 | Tranylcypromine Sulfate Tablets | Tablet | 10 mg | 100's Bottle | 64380-176-01 |
|
|
ANDA078329 | Ibuprofen Tablets | Tablet | 800 mg | 100's HDPE | 42543-964-06 |
|
|
500's HDPE | 42543-964-07 | ||||||
600 mg | 100's HDPE | 42543-965-06 | |||||
500's HDPE | 42543-965-07 | ||||||
400 mg | 100's HDPE | 42543-966-06 | |||||
500's HDPE | 42543-966-07 | ||||||
800 mg | 100's HDPE | 64380-807-06 | |||||
500's HDPE | 64380-807-07 | ||||||
600 mg | 100's HDPE | 64380-808-06 | |||||
500's HDPE | 64380-808-07 | ||||||
400 mg | 100's HDPE | 64380-809-06 | |||||
500's HDPE | 64380-809-07 | ||||||
ANDA090456 | Mycophenolate Mofetil Tablets | Tablet | 500 mg | 100's HDPE | 42543-989-06 |
|
|
500's HDPE | 42543-989-07 | ||||||
100's HDPE | 64380-725-06 | ||||||
500's HDPE | 64380-725-07 | ||||||
ANDA078109 | Olanzapine Orally Disintegrating Tablets | Tablet | 5 mg | 10's Blister | 64380-172-01 |
|
|
3 x 10's Blister | 64380-172-02 | ||||||
10 mg | 10's Blister | 64380-173-01 | |||||
3 x 10's Blister | 64380-173-02 | ||||||
15 mg | 10's Blister | 64380-174-01 | |||||
3 x 10's Blister | 64380-174-02 | ||||||
20 mg | 10's Blister | 64380-175-01 | |||||
3 x 10's Blister | 64380-175-02 | ||||||
ANDA079182 | Omeprazole and Sodium Bicarbonate for Oral Suspension | Oral Suspension | 20 mg/1.68 g | 1 Sachet | 64380-182-01 |
|
|
30's in carton | 64380-182-02 | ||||||
40 mg/1.68 g | 1 Sachet | 64380-183-01 | |||||
30's in carton | 64380-183-02 | ||||||
ANDA204559 | Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Oral Solution, 420 grams/11.2 grams/5.72 grams/1.48 grams/4 Liters | Oral Solution | Unflavored | 4 L Jug | 64380-768-21 |
|
|
Lemon flavor | 4 L Jug | 64380-769-21 | |||||
Orange flavor | 4 L Jug | 64380-770-21 | |||||
ANDA202935 | Hydrocodone Bitartrate and Acetaminophen Tablets | Tablet | 5 mg /325 mg | 100’s bottle | 64380-440-01 |
|
|
500’s bottle | 64380-440-02 | ||||||
1000’s bottle | 64380-440-03 | ||||||
7.5 mg /325 mg | 100’s bottle | 64380-441-01 | |||||
500’s bottle | 64380-441-02 | ||||||
1000’s bottle | 64380-441-03 | ||||||
10 mg /325 mg | 100’s bottle | 64380-442-01 | |||||
500’s bottle | 64380-442-02 | ||||||
1000’s bottle | 64380-442-03 | ||||||
ANDA210347 | Piroxicam Capsules | Capsule | 10 mg | 100's HDPE | 64380-842-06 |
|
|
20 mg | 100's HDPE | 64380-843-06 | |||||
20 mg | 500's HDPE | 64380-843-07 | |||||
ANDA210457 | Ketoconazole Tablets | Tablet | 200 mg | 100’s HDPE | 42543-827-06 |
|
|
500’s HDPE | 42543-827-07 | ||||||
100's HDPE | 64380-827-06 | ||||||
500's HDPE | 64380-827-07 | ||||||
2000's Bulk | 64380-827-47 | ||||||
ANDA211314 | Gabapentin Capsules | Capsule | 100 mg | 100's HDPE | 42543-867-06 |
|
|
500's HDPE | 42543-867-07 | ||||||
300 mg | 100's HDPE | 42543-868-06 | |||||
500's HDPE | 42543-868-07 | ||||||
400 mg | 100's HDPE | 42543-869-06 | |||||
500's HDPE | 42543-869-07 | ||||||
100 mg | 100's HDPE | 64380-867-06 | |||||
500's HDPE | 64380-867-07 | ||||||
300 mg | 100's HDPE | 64380-868-06 | |||||
500's HDPE | 64380-868-07 | ||||||
400 mg | 100's HDPE | 64380-869-06 | |||||
500's HDPE | 64380-869-07 | ||||||
1000's HDPE | 64380-869-08 | ||||||
ANDA209173 | Colchicine Tablets | Tablet | 0.6 mg | 30's HDPE | 64380-796-04 |
|
|
100's HDPE | 64380-796-06 | ||||||
ANDA215469 | Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (17.5 g/3.13 g/1.6 g) per 6 ounces | Oral Solution | 17.5 g/3.13 g/1.6 g per 6 ounces | 2 No of 177 mL bottle in a carton | 64380-116-01 |
|
|
177 mL bottle | 64380-116-02 | ||||||
ANDA209883 | Pregabalin Capsules | Capsule | 25 mg | 90's HDPE | 64380-815-05 |
|
|
50 mg | 90's HDPE | 64380-816-05 | |||||
10 X 10's Blister | 64380-816-30 | ||||||
75 mg | 90's HDPE | 64380-817-05 | |||||
10 X 10's Blister | 64380-817-30 | ||||||
100 mg | 90's HDPE | 64380-818-05 | |||||
10 X 10's Blister | 64380-818-30 | ||||||
150 mg | 90's HDPE | 64380-819-05 | |||||
10 X 10's Blister | 64380-819-30 | ||||||
200 mg | 90's HDPE | 64380-820-05 | |||||
225 mg | 90's HDPE | 64380-821-05 | |||||
300 mg | 90's HDPE | 64380-822-05 | |||||
ANDA090382 | Losartan Potassium Tablets | Tablet | 25 mg | 30's HDPE | 42543-933-04 |
|
|
90's HDPE | 42543-933-05 | ||||||
1000's HDPE | 42543-933-08 | ||||||
50 mg | 30's HDPE | 42543-934-04 | |||||
90's HDPE | 42543-934-05 | ||||||
1000's HDPE | 42543-934-08 | ||||||
100 mg | 30's HDPE | 42543-935-04 | |||||
90's HDPE | 42543-935-05 | ||||||
1000's HDPE | 42543-935-08 | ||||||
25 mg | 30's HDPE | 64380-933-04 | |||||
90's HDPE | 64380-933-05 | ||||||
1000's HDPE | 64380-933-08 | ||||||
50 mg | 30's HDPE | 64380-934-04 | |||||
90's HDPE | 64380-934-05 | ||||||
1000's HDPE | 64380-934-08 | ||||||
100 mg | 30's HDPE | 64380-935-04 | |||||
90's HDPE | 64380-935-05 | ||||||
1000's HDPE | 64380-935-08 | ||||||
ANDA215311 | Ibuprofen Oral Suspension | Oral Suspension | 100mg/5ml | 5 ml unit dose cups | 64380-997-01 |
|
|
Carton - 10’s cups | 64380-997-02 | ||||||
118 ml Bottle | 64380-997-03 | ||||||
473 ml Bottle | 64380-997-04 |
